Mesh Medical Device News Desk, February 21, 2017 ~Ethicon Wants Another Chance to Overturn the Huskey Pelvic Mesh Case by arguing that the defense team should have been able to introduce assurances about safety and efficacy by the Food and Drug Administration concerning the TVT-O transvaginal mesh.
On February 9, 2017, Ethicon filed for a rehearing of the Huskey v Ethicon case (Fourth circuit No. 15-2118) in an attempt to reverse the appellate decision which affirmed the jury award.
In essence, J&J wants a second bite of the apple.
Following the nine-day Jo Huskey trial, which concluded September 5, 2014, the jury returned a verdict for Jo Huskey and her husband on their design defect, failure to warn, and loss of consortium claims over her TVT-O implant. Huskey was awarded $3.27 million.
Ethicon immediately appealed and asked for a judgment in its favor, or for a new trial.
Both were denied.
Then on January 26, 2017, the Fourth Circuit Court of Appeals issued its ruling by deciding to uphold the jury verdict, essentially ending the appeals process for J&J.
Here is the appeals court decision. That should have been the end of the appeals process.
On February 10th Ethicon tried again with the Fourth Circuit, asking it to review its decision upholding Huskey v Ethicon.
If Judge Goodwin’s ruling is allowed to stand, it will essentially bar any FDA discussion from the 60,000 or so product liability cases pending before Judge Goodwin, argues Ethicon.
“The clear takeaway from the Panel’s decision is that district courts may now exclude all FDA evidence in trials addressing the safety of FDA-regulated Class II devices. Indeed, if the FDA’s conclusion after a comprehensive post-market review that a device is “safe and effective” is not admissible, then no FDA evidence is,” says the petition, written by Charles Lifland of O’Melveny & Myers LLP, representing Ethicon.
With that dire prediction, J&J lawyers want a rehearing En Banc (meaning all eligible, active judges of the Fourth Circuit).
Listen (here) to the arguments recorded here of Dave Thomas (Ethicon) and Fidelma Fitzpatrick (Plaintiffs).
The defense is represented by lawyers from O’Melveny & Myers LLP, Christy Jones (Butler Snow) and Dave Thomas of Charleston, WV.
WHAT WAS DECIDED
In the Huskey trial, Judge Goodwin disallowed discussion of the 510(k) approval process of the Food and Drug Administration to be presented to the jury under Federal Rule of Evidence 403.
It was the TVT-O that was implanted in Ms. Huskey which the jury decided was defectively designed. J&J argued the Goodwin court erred in denying it a judgment in its favor as a matter of law on all five claims – strict liability and negligent design defect; strict liability and negligent failure to warn; and loss of consortium – claiming Huskey’s lawyers didn’t prove their claims.
The appeals court said they did.
The Huskeys proved that polypropylene mesh will incite a foreign body reaction when implanting that “will continue to attack it in this way until it’s removed or destroyed or it’s gone.” That was according to their expert in chemical engineering.
Dr. Bruce Rosenzweig echoed the same design defect when he said the more mesh the more foreign body response, especially heavyweight mesh.
Ethicon’s former employee Dr. Brigitte Hellhammer said lighter weight mesh could treat SUI and that heavier mesh would likely shrink.
Dr. Jerry Blaivas testified Mrs. Huskey had severe scarring and suffered chronic pelvic pain, a “reaction to the mesh.”
That added up to the conclusion that Ethicon’s use of heavyweight polypropylene mesh in the TVT-O was a design defect that caused inflammation and pelvic pain in Ms. Huskey.
The jury’s decision was not contrary to the clear weight of the evidence the appeals court decided in upholding the jury verdict.
The panel also rejected Ethicon argument under “comment K” that some products are unavoidably unsafe, though not unreasonably dangerous, shielding Ethicon from liability.
Huskey is from Illinois and state law determines if a specific product is covered by comment k doctrine (here).
WHAT’S LEFT TO DECIDE? THE FDA
J&J lawyers say there were four pieces of evidence that were excluded from the Huskey trial that would have made a difference for the company.
The 510(k) evaluation process
The 2011 FDA Advisory Committee said mesh slings are safe and effective
A 2013 published FDA guidance on the Advisory committee’s conclusions
The fact that Ethicon’s Prolene suture is made of polypropylene like the TVT-O
Judge Goodwin excluded the FDA discussion in Huskey because it could confuse the issues and mislead the jury, not to mention take jurors down the long, complicated and jargon-filled world of FDA rules and regulations.
Lawyers for J&J say the FDA “comprehensively regulates medical devices,” including the TVT-O, considered the “Gold Standard” by medical societies. They go on to praise the FDA and its “robust regulatory history.” The defense team heralds the FDA’s 510(k) clearance of the TVT-O mesh kit (implanted in Ms. Huskey) along with its presumption of safety and efficacy.
J&J contents that the FDA approved Prolene suture that makes up the TVT-O kit was cleared “based on their established history of safe and effective use.”
J&J says the en banc should “consider this critically important issue.”
Most readers of Mesh News Desk understand that the 510(k) approval process can not accurately be called robust. Rather, medical devices make it to market, after a shuffling of paperwork and a declaration by the manufacturer that its new device is substantially similar to one already on the market. There are no clinical trials required. ###